101000

Organization name

Osstell AB

SRN

SE-MF-000002162

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW014

  EUDAMED did not publish a description for this code.

Primary placement in Sweden; available across 32 countries total.

Trade name

not provided

UDI-DI code

D-OsstellIDxWE

Basic UDI-DI

B-OsstellIDxWE

Reference / catalog number

101000

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The Osstell IDx is a fast, non-invasive and easy to use system to determine implant stability and to assess the process of osseointegration – without jeopardizing the healing process. It provides the accurate, consistent, and objective information needed to make well-founded decisions. It is the only objective quality assurance method that gives you an early warning if osseointegration isn’t progressing as expected, bringing new certainty to you and your patient.

Additional information URL

https://www.osstell.com/

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Q0199ODONTOLOGY DEVICES - OTHER